CurrentUnitedHealthcarePolicy CSLA2025D00115D

Korsuva (Difelikefalin) — Coverage Criteria (Louisiana)

Defines UnitedHealthcare Community Plan coverage criteria for Korsuva (difelikefalin) to treat moderate-to-severe pruritus associated with chronic kidney disease in adults receiving hemodialysis in Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyKorsuva (Difelikefalin) — Coverage Criteria (Louisiana)

Policy CodePolicy CSLA2025D00115D

Change TypeAdministrative update

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required; initial approvals limited to a maximum of 12 months when all initial criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated Background and References sections to reflect the most current information.

Adults on hemodialysisPopulation specified for coverage

≤ 12 monthsInitial authorization duration limit

≤ 12 monthsContinuation authorization duration limit

KALM (n=851)Clinical trials supporting efficacy

Not studied in peritoneal dialysisLimitation of use

Coverage Criteria for Korsuva (difelikefalin)

Initial Therapy

Covered when ALL of the following are met for initial therapy

Initial Therapy: Diagnosis of moderate-to-severe pruritus associated with chronic kidney disease; patient is on hemodialysis; pruritus is not attributed to a cause other than end-stage renal disease or its complications (e.g., pruritic dermatologic disease, cholestatic liver disease); pruritus is not limited to occurring only during the dialysis session; pruritus is not localized to just the palms of the hands; history of failure, contraindication, or intolerance to other pruritus treatments (e.g., antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin); prescribed by or in consultation with a nephrologist; dosing is in accordance with the United States Food and Drug Administration approved labeling; initial authorization will be for no longer than 12 months.all conditions required

Each bullet from policy must be satisfied

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy

Policy Summary

PayerUnitedHealthcare

PolicyKorsuva (Difelikefalin) — Coverage Criteria (Louisiana)

Policy CodePolicy CSLA2025D00115D

Change TypeAdministrative update

Effective DateJul 1, 2025

Next Review Date

Key ActionPrior authorization is required; initial approvals limited to a maximum of 12 months when all initial criteria are met.

SourceLink

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Prior Authorization, Documentation, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are limited to a maximum of 12 months when ALL initial criteria are met. Reauthorization is limited to 12 months and requires documentation of continued clinical benefit.

Initial and reauthorization duration: <= 12 months
Prescriber requirement: prescribed by or in consultation with a nephrologist

Prior Authorization

Prior Treatment Requirement

Must document history of failure, contraindication, or intolerance to other pruritus treatments prior to initiation (examples: antihistamines, corticosteroids, gabapentin, pregabalin, capsaicin, topical measures).

Required prior treatments: antihistamines, corticosteroids, gabapentin or pregabalin, topical therapies (unless contraindicated)

Documentation Required

Required Documentation for Initial Authorization

For initial authorization, include documentation of: diagnosis of moderate-to-severe CKD-associated pruritus; evidence the patient is on hemodialysis; pruritus severity and prior treatment attempts; prescriber/nephrology involvement; and planned dosing consistent with FDA labeling.

Initial documentation must show: diagnosis of CKD-associated pruritus, hemodialysis status, severity baseline, prior therapy failures/contraindications/intolerances, nephrology prescriber or consult, intended dosing per FDA label

Documentation Required

Required Documentation for Continuation

For continuation/reauthorization, provide documentation of a positive clinical response (reduction in itch from baseline), ongoing nephrology involvement (prescriber or consult), and dosing consistent with FDA-approved labeling.

Continuation documentation: objective or clinician-assessed reduction in itch vs baseline, nephrology prescriber/consult note, dosing adherence to FDA label

Denial Risk

Denial Risk for Unsupported Populations

Therapy may be denied when used for patients not on hemodialysis, for pruritus attributable to causes other than end-stage renal disease or its complications, for pruritus limited to dialysis sessions only, or for pruritus localized solely to the palms. Korsuva is not recommended for patients on peritoneal dialysis.

Not covered/denial risk: patients not on hemodialysis
Not covered/denial risk: pruritus due to other causes (e.g., dermatologic disease, cholestatic liver disease)
Not covered/denial risk: pruritus only during dialysis sessions or localized only to the palms
Not recommended: peritoneal dialysis patients (no study data)

Key Definitions

Moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP)

DefinitionSystemic itching in adults undergoing hemodialysis that is clinically assessed as moderate-to-severe and not attributable to other causes

Population specifiedAdults undergoing hemodialysis with moderate-to-severe pruritus (CKD-aP)

Exclusions / attributionPruritus must not be due to other causes (e.g., pruritic dermatologic disease, cholestatic liver disease) and not limited to dialysis sessions or localized only to the palms

Clinical relevanceAssociated with poor sleep, depression, reduced quality of life, increased infection risk, and increased mortality

FDA indicationKorsuva is indicated for moderate-to-severe CKD-associated pruritus in adults on hemodialysis; not studied in peritoneal dialysis

OpenPayer

Korsuva (Difelikefalin) — Coverage Criteria (Louisiana)

Coverage Criteria for Korsuva (difelikefalin)

Applicable Codes and Trial Thresholds

Prior Authorization, Documentation, and Denial Risk

Key Definitions

Background